Data Integrity

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report. 

To this end, in this 90-minute accredited course, we will discuss effective batch record review. Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale.

THIS TRAINING IS PART OF OUR FDA READINESS PROFESSIONAL CERTIFICATION

• To enroll into the complete FDA Readiness Professional Certification Program CLICK HERE.  This program includes 10 specific online courses for $2050.
• To learn more about our certification programs, visit our website at Certifications

To register for this individual course ONLY, click the Register Now button below.